NDC 33342-277

Darifenacin

Darifenacin

Darifenacin is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is Darifenacin Hydrobromide.

Product ID33342-277_4b4427c3-48f9-4db3-9174-4cac6ae1e0ac
NDC33342-277
Product TypeHuman Prescription Drug
Proprietary NameDarifenacin
Generic NameDarifenacin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-07-29
Marketing CategoryANDA / ANDA
Application NumberANDA207302
Labeler NameMacleods Pharmaceuticals Limited
Substance NameDARIFENACIN HYDROBROMIDE
Active Ingredient Strength15 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 33342-277-07

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-07)
Marketing Start Date2017-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33342-277-07 [33342027707]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207302
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-29

NDC 33342-277-12 [33342027712]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207302
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-29

NDC 33342-277-10 [33342027710]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207302
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-29

Drug Details

Active Ingredients

IngredientStrength
DARIFENACIN HYDROBROMIDE15 mg/1

OpenFDA Data

SPL SET ID:7ae60119-e22c-4806-a5d8-db7c9e8984a2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485423
  • 485421
    • UPC Code
  • 0333342277107
  • 0333342276070
  • 0333342276100
  • 0333342277077

    • Pharmacological Class

    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]

    Medicade Reported Pricing

    33342027710 DARIFENACIN ER 15 MG TABLET

    Pricing Unit: EA | Drug Type:

    33342027707 DARIFENACIN ER 15 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Darifenacin" or generic name "Darifenacin"

    NDCBrand NameGeneric Name
    0591-4375Darifenacindarifenacin
    0591-4380Darifenacindarifenacin
    13668-202DarifenacinDarifenacin
    13668-203DarifenacinDarifenacin
    16571-767DarifenacinDarifenacin
    16571-768DarifenacinDarifenacin
    33342-276DarifenacinDarifenacin
    33342-277DarifenacinDarifenacin
    46708-223DARIFENACINDARIFENACIN
    46708-224DARIFENACINDARIFENACIN
    52605-067DarifenacinDarifenacin Hydrobromide
    52605-068DarifenacinDarifenacin Hydrobromide
    59746-516darifenacindarifenacin hydrobromide
    59746-517darifenacindarifenacin hydrobromide
    62332-223DARIFENACINDARIFENACIN
    69097-432DarifenacinDarifenacin
    69097-431DarifenacinDarifenacin
    62332-224DARIFENACINDARIFENACIN
    65862-862DarifenacinDarifenacin
    65862-861DarifenacinDarifenacin
    0430-0170Enablexdarifenacin
    0430-0171Enablexdarifenacin
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